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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05548179
Other study ID # 87688730
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date October 2025

Study information

Verified date September 2022
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical study participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date October 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient has self-identified as planning to enroll in an interventional clinical trial - Patient has been diagnosed with leiomyosarcoma - Patient is a minimum of 18 years or older Exclusion Criteria: - Patient does not understand, sign, and return consent form - Inability to perform regular electronic reporting - Patient is pregnant - ECOG score of 4

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

References & Publications (3)

Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20. — View Citation

Kasper B, D'Ambrosio L, Davis EJ, Ingham M, Broto JM, Trent JC, van Houdt WJ, Van Tine BA. What Clinical Trials Are Needed for Treatment of Leiomyosarcoma? Curr Treat Options Oncol. 2022 Mar;23(3):439-449. doi: 10.1007/s11864-021-00928-y. Epub 2022 Mar 11. — View Citation

Serrano C, George S. Leiomyosarcoma. Hematol Oncol Clin North Am. 2013 Oct;27(5):957-74. doi: 10.1016/j.hoc.2013.07.002. Epub 2013 Aug 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who decide to enroll in an leiomyosarcoma clinical trial 3 months
Primary Rate of patients who remain in leiomyosarcoma clinical trial to trial completion 12 months
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